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Набор по приглашению NCT05773950

Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention

Без фазы С лечением Postoperative Nausea and Vomiting Gynecologic Surgical Procedures Laparoscopy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: fosaprepitant, normal saline.
Кому может быть актуально
Состояния в реестре: Postoperative Nausea and Vomiting, Gynecologic Surgical Procedures, Laparoscopy. Базовые параметры: 19 лет — 49 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of Dual Therapy of Dexamethasone and Palonosetron and Triple Therapy of Dexamethasone, Palonosetron, Fosaprepitant for Postoperative Nausea and Vomiting Prevention: a Randomized Controlled Trial

Обзор

As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.

Подробное описание

Intervention

1. Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg, 2. Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,

Вмешательства

  • Препарат fosaprepitant
    The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. In the experimental group, the subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
  • Препарат normal saline
    On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.

Первичные конечные точки

  • the incidence of Postoperative nausea and vomiting [Срок оценки: during 24 hours after surgery]
Вторичные конечные точки (10)
  • the incidence of Postoperative nausea and vomiting [Срок оценки: during post-anesthesia care unit stay, during 6 hours after surgery]
  • the severity of Postoperative nausea and vomiting [Срок оценки: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery]
  • rescue antiemetics [Срок оценки: during 24 hours after surgery]
  • time to rescue antiemetics [Срок оценки: during 24 hours after surgery]
  • postoperative pain at rest and couging [Срок оценки: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery]
  • opioid consumption [Срок оценки: during 24 hours after surgery]
  • Any adverse event [Срок оценки: during 24 hours after surgery]
  • Time to normal diet [Срок оценки: during 24 hours after surgery]
  • Qualityof recovery from surgery and anesthesia [Срок оценки: during 24 hours after surgery]
  • Time to first flatus [Срок оценки: during in hospital stay, an average of 5 days]

Критерии участия

Критерии включения

  • Patients undergoing laparoscopic gynecological surgery.
  • Adults between the ages of 18 and 50
  • American Society of Anesthesiologists Physical Status (ASA physical status I, II

Критерии исключения

  • American Association of Anesthesiologists physical standards (ASA physical status III or higher)
  • Children under the age of 19
  • Adults over 49 years of age
  • Diabetes Mellitus
  • Pregnant or lactating women
  • Patients with a history of allergy or contraindications for use of the study drug
  • Patients who did not understand this study or expressed their refusal.
  • Patients with a history of serious psychologic disease that may affect the patient evaluation
  • Patients taking serotonergic drugs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

South Korea · 1 центр
  • Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT05773950 · SMC2022-12-050-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗